iCCaRE Consortium Pilot Project 1: Feasibility of a Point of Prostate Cancer Diagnosis Intervention for Newly Diagnosed Black Men

January 15, 2026 updated by: Mayo Clinic
This study is being done to determine the acceptance and effectiveness of a virtual robot assistant model at a urology clinic.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. Plan and develop a PPCD iCCaRE ViRA model that will provide social determinants of health (SDOH) navigation services, psycho-oncology support and emotional support using qualitative formative research.

II: Establish the acceptance and usability of the iCCaRE ViRA among 50 African American/Black men (AA/BM) at local Jacksonville sites.

OUTLINE: This is an observational study. Participants are assigned to 1 of 4 cohorts.

COHORT I: Consumer advocates attend a focus group on study.

COHORT II: Clinicians complete interviews on study.

COHORT III: CaP survivors test the virtual health intervention, complete a survey, and attend a focus group on study.

COHORT IV: Patients complete surveys and participate in the virtual health intervention on study. Patients complete survey and an interview during follow up.

Study Type

Observational

Enrollment (Estimated)

53

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224-9980
        • Recruiting
        • Mayo Clinic in Florida
        • Contact:
        • Principal Investigator:
          • Folakemi T. Odedina, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

iCCaRE Consortium consumer advocates, clinicians as part of the iCCaRE Consortium Translational Research & Clinical Intervention Services. Community Advisory Board (CAB) and non-CAB iCCaRE consumer advocates. Patients with an abnormal PSA and/or DRE diagnosed with prostate cancer in the state of Florida.

Description

Inclusion Criteria:

  • AIM 1: iCCaRE Consortium consumer advocates
  • Clinicians who are part of the Translational Research & Clinical Intervention Services (TRaCIS)
  • AIM 2 ALPHA TESTING: iCCaRE consumer advocates [2 Community Advisory Board (CAB) and 1 non-CAB]

  • AIM 2 BETA TESTING-PATIENTS:

    • An African American/Black male
    • A patient who has been diagnosed with prostate cancer in Florida at any time in their life, and/or within the previous 6 months has had an abnormal Prostate-Specific Antigen (PSA) lab value and/or Digital Rectal Examination (DRE)
    • Minimum age of 30 years old
    • Consent to participating in the intervention

Exclusion Criteria:

  • AIM 2 BETA TESTING-PATIENTS:

    • Patients who are not African American/Black males
    • Patients not diagnosed with prostate cancer in Florida at any time in their life, or within the previous 6 months has not had a normal PSA lab value and/or DRE
    • Older than 80 years old
    • Are not willing to consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational cohort I
Consumer advocates attend a focus group on study.
Other: Focus group
Attend a focus group session
Observational cohort II
Clinicians complete interviews on study.
Other: Clinician Interviews
Participate in clinician interviews
Observational cohort V
Patients complete surveys and participate in the virtual health intervention on study. Patients complete survey and an interview during follow up.
Other: Survey
Complete a follow-up survey
Other: Follow-up Interview
Participate in a follow-up interview
Other: Virtual Health Intervention
Participate in the virtual health intervention
Observational cohort III
CaP survivors test the virtual health intervention, complete a survey, and attend a focus group on study.
Other: Focus group
Attend a focus group session
Other: Intervention testing
Test the virtual health intervention
Other: Survey
Complete a follow-up survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usability of the iCCaRE ViRA
Time Frame: Baseline; follow-up interview 3-4 months post visit
Will be assessed by patient immediate reaction and patient delayed feedback.
Baseline; follow-up interview 3-4 months post visit
Point of Prostate Cancer Diagnosis (PPCD) iCCaRE Virtual Reality Assistant (ViRA) model
Time Frame: Up to 4 months
Will be assessed by the length of time needed to create the model. PPCD iCCaRE ViRA model development will be guided by the Translational Research & Clinical Intervention Services (TRaCIS) and Digital Health & Human Services (DHHS) core sections of the Inclusive Cancer Care Research Equity (iCCaRE) Consortium. The consortium's scientific team and Community Advisory Board (CAB) will participate in making decisions about how to proceed with the development of the ViRA Intervention and Communication Strategy Plan (ICoSP). This application (app) will be evaluated in Outcomes 2 and 3. The PPCD iCCaRE ViRA app will provide social determinants of health (SDOH) navigation services, psycho-oncology support and emotional support using qualitative formative research.
Up to 4 months
Acceptance of the iCCaRE ViRA
Time Frame: Baseline; follow-up interview 3-4 months post visit
Will be assessed by patient immediate reaction and patient delayed feedback.
Baseline; follow-up interview 3-4 months post visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

Congressionally Directed Medical Research Programs

Investigators

  • Principal Investigator: Folakemi T. Odedina, PhD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

July 30, 2024

First Submitted That Met QC Criteria

July 30, 2024

First Posted (Actual)

August 2, 2024

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MC220501 (Other Identifier: Mayo Clinic in Florida)
  • W81XWH2210968 (Other Grant/Funding Number: Department of Defense)
  • NCI-2024-05156 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • 22-001412 (Other Identifier: Mayo Clinic Institutional Review Board)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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